Atlas FDA

DYW

42 FDA 510(k) clearances · Product code

78 daysmedian time to decision
257 days90th percentile
42clearances measured

FDA profile

Official device name
Bracket, Plastic, Orthodontic
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5470
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2002: 10 · 2003: 2 · 2004: 5 · 2005: 3 · 2006: 2 · 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Carriere® Motion Pro® Clear Bite Corrector (K252760)Ortho Organizers, Inc.2025-11-27
Composite Orthodontic Brackets and Buttons (K251196)Ec Certification Service GmbH2025-04-21
Braces on Demand Bracket (K201940)Braces on Demand, Inc.2020-12-03
Blue Sky Bio Computerized Orthodontic Bracket System (K182338)Blue Sky Bio2018-11-09
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES (K180718)Tomy, Inc.2018-10-30
Carriere Motion Clear Class II (K160720)Ortho Organizers, Inc.2016-11-28
CompleClear Plastic Orthodontic Bracket and Wire Appliance (K150830)Oracrew2016-08-26
Exceed Tx (K150702)Great Lakes Orthodontics, Ltd.2016-03-24
COMPOSITE ORTHODONTIC BRACKETS (K140807)Ortho Specialties2014-11-12
INSIGNIA DIGICAST (K123118)Ormco Corp.2013-03-26
INSIGNIA WITH ITERO (K123416)Ormco Corp.2013-03-13
INSIGNIA (K121524)Ormco Corp.2012-08-09
SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE (K110796)Biomers Products, LLC2011-03-31
CLEARARCH (K101676)Ormco Corp.2010-09-13
ORTHOCAD IQ (K082207)Cadent, Inc.2009-10-23
ELATION MB METAL REINFORCED PLASTIC BRACKET (K092030)Dentsply Interntional2009-07-24
BIOMERS TRANSLUCENT ORTHODONTIC WIRE (K081143)Biomers Product, LLC2008-05-02
OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 (K071055)Ultradent Products, Inc.2007-05-03
LINGLOCK (K061042)Sybron Dental Specialties2007-01-19
EVERSTICK A&O (K051953)Stick Tech , Ltd.2006-03-21
ORTHODONTIC POLYMER COMPOSITE BRACKET (K053055)Gestenco International AB2005-12-22
DAMON 3 MODIFIED (K052477)Ormco Corp.2005-11-30
CP BRACKET SYSTEM (K052370)Dentsply International2005-11-01
RAVE COMPOSITE BRACKET (K052714)FDA Agents2005-10-26
MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM (K050730)Ultradent Products, Inc.2005-03-31
ORTHODONTIC COMPOSITE BRACKET SYSTEM (K032625)Ultradent Products, Inc.2004-02-26
DAMON FT (K032408)Sybron Dental Specialties, Inc.2003-10-15
ORTHODONTIC BRACES (K981433)Midwest Orthodontic Mfg.1998-06-25
REFLECTIONS (K973776)Cdb Corp.1997-11-21
SPIRIT MB (K955333)Ormco Corp.1996-01-04
GLOWING SPIRITS (K951239)Ormco Corp.1995-07-19
ORTHODONITC METAL REINFORCED PLASTIC BRACKET (K942826)Gac Intl., Inc.1994-12-14
METAL-LINED TRANSCEND CERAMIC BRACKET (K944286)Unitek Corp.1994-11-29
SPIRIT MB (K943245)Sybron Dental Specialties, Inc.1994-08-23
GLENROE PLASTIC BRACKET (K932920)Glenroe Technologies1993-08-24
LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS (K900809)Lee Pharmaceuticals1990-06-28
SPIRIT (K896913)Ormco Corp.1990-03-08
ORTHODONTIC PLASTIC BRACKET (K891372)American Orthodontics1989-03-31
PLASTIC BRACKETS (K874227)Advanced Orthodontics Systems, Inc.1987-12-29
UNITEK CERAMIC BRACKET SYSTEM (K861965)Unitek Corp.1986-06-09
CERAMIBOND (K802899)Zulauf, Inc.1980-12-19
BRACKET, METAL REINFORCED PLASTIC (K780239)Ormco Corp.1978-03-15

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